signal of a serious risk
- Guideline or reference source
- CDISC Glossary of terms
- Definition
- Information related to a serious adverse drug experience associated with use of a drug and derived from—(a) a clinical trial; (b) adverse event reports; (c) a post-approval study; (d) peer-reviewed biomedical literature; (e) data derived from the post-market REMS.
- Related Term
- serious adverse event
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